Amendment timeline
Therapeutic Goods Act 1989
Therapeutic Goods Act 1989 (Cth)
About this Act
Federal Act establishing the regulatory framework for therapeutic goods (medicines, medical devices, biologicals) in Australia. Administered by the Therapeutic Goods Administration (TGA). Goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before supply unless exempt. Heavily amended in 2024 to bring vaping products into prescription-medicine framework and to address genetic test insurance discrimination.
- Original Royal Assent
- 21 December 1989
- Original commencement
- 15 February 1991
Amendment timeline
Chronological list, oldest to newest. Each entry cites the legislation.gov.au compilation or as-made source and, where available, regulator guidance.
Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024
Royal Assent
28 June 2024
Commencement
1 Jul 2024
What changed
Implemented the vaping product reforms: prohibited the import, manufacture, supply and advertising of non-therapeutic disposable single-use vapes outside the pharmacy-supply model. Limited therapeutic vapes (nicotine vaping products for smoking cessation) to pharmacy supply with strict TGA licensing, plain packaging, restricted flavours and concentration caps. Earlier border controls on disposables had been in place since January 2024.
Who's affected
All retailers and importers of vaping products; pharmacists; ABF (border control); TGA-licensed therapeutic vape sponsors.
Read more
Therapeutic Goods Amendment (2024 Measures No. 1) Act 2024
Royal Assent
10 September 2024
Commencement
Various 2024-2025
What changed
Technical amendments to TGA processes including a streamlined pathway for sunscreen reformulation, faster approval for novel low-risk biologicals, and expanded post-market monitoring of medical devices following the surgical-mesh class actions. Also tightened scheduling of cosmetic injectables (e.g. peptide injectables).
Who's affected
Sponsors of therapeutic goods; medical device manufacturers; cosmetic injectable practitioners.
What's coming next
Genetic Test Insurance Discrimination Bill — introduced 2025, proposing a total ban on the use of predictive genetic test results in life insurance underwriting (currently industry self-regulates via the FSC Moratorium). Awaiting passage through Parliament. Cosmetic injectable practitioner regulation is being considered through TGA Scheduling Committee — proposed restrictions on advertising and prescribing of botulinum toxin and dermal fillers in non-medical settings. Patient-side compounding further reform expected in late 2026.
Why this matters now
The vaping reforms reshaped a multi-billion-dollar industry in a single quarter. Retailers continuing to supply disposable vapes face criminal exposure (max $2.2M penalty per offence). Pharmacists face new dispensing protocols. The genetic test insurance ban (if passed) would change life insurance underwriting fundamentally. Cosmetic injectable practitioners face increasing TGA scrutiny — the 'cowboy cosmetic clinic' crackdown.
Frequently asked
Can convenience stores still sell vapes?
No — from 1 July 2024, vaping products (including disposable single-use vapes whether marketed as containing nicotine or not) can only be supplied through pharmacies, and only after the pharmacist has assessed therapeutic suitability. Non-pharmacy retail supply is a criminal offence under s 41MA.
Do nicotine vapes need a prescription?
From 1 October 2024: nicotine vapes are available without prescription through pharmacies for adults 18+ following pharmacist consultation. Prescription is required for children under 18. The earlier Schedule 4 prescription-only requirement was eased to allow pharmacist-supply on consultation.
What's the Genetic Test Insurance Discrimination Bill?
A 2025 Bill (not yet enacted) that would prohibit life insurers from requiring or using predictive genetic test results in underwriting risk-rated life, total and permanent disability, or income protection insurance. Replaces the current FSC industry moratorium with a legislative ban.
Are cosmetic injectables regulated by the TGA?
Botulinum toxin (e.g. Botox) is Schedule 4 prescription-only — requires medical or nurse practitioner prescribing. Dermal fillers are medical devices on the ARTG. The TGA has cracked down on advertising and prescribing standards under existing law and is consulting on tightened restrictions in cosmetic settings.
How does ARTG entry work?
Sponsors apply to the TGA for listing (lower-risk goods, ARTG-L) or registration (higher-risk, ARTG-R). Listed goods have pre-vetted ingredients and self-declaration; registered goods undergo TGA evaluation. Supply without ARTG entry is generally illegal under s 19B (with exemptions including the Personal Importation Scheme and authorised prescriber pathway).
Other amendment timelines
Rules Mate summarises and links to legislation.gov.au and regulator guidance. We do not republish statutory text. Every date in this timeline has been verified against the Federal Register of Legislation as at 6 June 2026. Always verify against the live source before acting. Compliance tools, not legal advice. Consult a qualified professional.